Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

scholarly journals Insertion of Intrauterine Contraceptive Device at Cesarean Section: Randomized Clinical Trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
A G A Elkholy ◽  
M S Sweed ◽  
H N Bartella
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Randomized Clinical Trial ◽  
Breast Feeding ◽  
Health Care Providers ◽  
Maternity Hospital ◽  
Contraceptive Device ◽  
Care Providers ◽  
University Hospitals ◽  
Expulsion Rate

Abstract Background Postpartum period is highly vulnerable period to unintended pregnancy as there are limited contraceptive options available in the breast feeding women. At the same time ovulation is highly unpredictable in non breast feeding or non exclusive breast feeding women. an ideal time to begin contraception, as women are highly motivated to adopt contraception at this time, which also has the advantages of being convenient for both women and health care providers. Objective To evaluate and compare the efficacy of IUD (Pregna T Cu 380A) insertion at cesarean section and after puerperium in terms of expulsion rate, pain and amount of bleeding. Patients and Methods This study is a randomized Clinical Trial that was conducted at Ain Shams University Maternity Hospital during the period from December 2017 to May 2018. The study was approved by institute ethics committee of Ain Shams University Hospitals. Results There were no statistical significant differences in the rates of wound infection, postoperative pain, volume of bleeding, signs of infection, additional analgesic needs, dyspareunia and number of days till bleeding stops between both groups. There was no statistical significant between both groups as regard expulsion of IUD in the present study. Conclusion IUD is a contraceptive device which is commonly inserted after puerperium. This study will focus on insertion IUD during cesarean section.

scholarly journals Effectiveness of Acromioclavicular Joint Mobilization and Physical Therapy vs Physical Therapy Alone in Patients with Frozen Shoulder: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Bina Eftekharsadat ◽  
Behzad Izadseresht ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Acromioclavicular Joint ◽  
Frozen Shoulder ◽  
Secondary Outcome ◽  
Control Group ◽  
Joint Mobilization ◽  
Active Abduction

Abstract Background: Frozen shoulder (FS) is a prevalent musculoskeletal condition characterized by an often prolonged pain, disability and limited active and passive range of motion (ROM), however its management remains challenging yet. The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and physical therapy versus physical therapy in treatment of FS.Methods: In this single-blind randomized clinical trial, patients with diagnosis of FS were randomly allocated into mobilization + physical therapy (n=28) as experiment group, and physical therapy (n=28) as control group in two outpatient clinics of Tabriz University of Medical Sciences, Iran. The primary outcomes were self-reported shoulder pain-related disability measured by the Shoulder Pain and Disability Index (SPADI) questionnaire and goniometric assessment of shoulder ROM. The secondary outcome was the Visual Analogue Scale (VAS). Measures were performed at the baseline, immediately and one month after beginning the treatments.Results: Totally 51 patients with 25.73 ± 6.88 years old of age completed the study and their data were analyzed. VAS, SPADI, pain and disability improved more significantly in experiment group compared to control group immediately [-4.63 (-5.58- -3.67) vs. -2.22 (-2.96- -1.47), p<0.001; -23.08 (-28.63- -17.53) vs. -13.04 (-17.93- -8.16), p=0.008; -26.00 (-31.71- -20.29) vs. -16.35 (-23.39- -9.31), p=0.034 and -21.25 (-29.11- -13.39) vs. -10.98 (-17.53- -4.43), p=0.042, respectively] and one month after beginning of treatment [-5.58 (-6.45- -4.72) vs. -3.61 (-4.60- -2.62), p<0.001; -33.43 (-40.85- -26.01) vs. -20.03 (-26.00- -14.07), p=0.001; --42.83 (-49.09- -36.57) vs. -25.57 (-33.92- -17.21), p<0.001 and -27.55 (-36.19- -15.94) vs. -16.58 (-24.48- -8.67), p=0.041, respectively]. Active abduction ROM was also improved more significantly immediately after treatment in experiment group compared to control group [25.83 (11.45- 40.13) vs. 10.17 (1.02- 19.15), p=0.025], however there were no significant differences between two groups concerning other measured ROMs immediately and one month after treatment (all p>0.05). Conclusions: Acromioclavicular mobilization along with conventional physical therapy was more efficient in decreasing pain and disability and improving active abduction ROM compared to physical therapy in patients with FS. These findings would suggest a new therapeutic method for shoulder disorders with pain and disability.Trial registrationwww.irct.ir, IRCT20100605004104N7, registered 06.01.2019 (https://www.irct.ir/trial/35900)

scholarly journals Effectiveness of Ginger in the Treatment of Type 2 Diabetes Mellitus: A Pilot Study of the Randomized Clinical Trial Type

Aquichan ◽  
2021 ◽  
Vol 21 (1) ◽  
pp. 1-14
Author(s):  
Gerdane Celene Nunes Carvalho ◽  
Jose Claudio Garcia Lira Neto ◽  
Lívio César Cunha Nunes ◽  
Ana Maria Parente Garcia Alencar ◽  
Regina Lúcia Lino Marques ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Pilot Study ◽  
Randomized Clinical Trial ◽  
Trial Type ◽  
Secondary Outcome ◽  
Lipid Levels

Objective: To analyze the effectiveness of ginger in the reduction of the glycemic, lipid and anthropometric levels in people with Type 2 Diabetes Mellitus. Materials and method: A double-blind pilot study of the randomized clinical trial type, conducted between October 2017 and January 2018. The inclusion criteria were as follows: individuals with type 2 diabetes, aged from 18 to 80 years old, using oral antidiabetic drugs, and with glycated hemoglobin values between 7 % and 10 %. The participants were randomized and allocated in two different groups. In the experimental group, the participants used 1.2 g of ginger and, in the control group, 1.2 g of placebo. The primary outcome was the reduction in blood glucose. The reduction in the lipid and anthropometric levels was the secondary outcome. The intervention lasted four weeks. Results: A total of 21 participants were included in the study. The use of 1.2 g of ginger resulted in noticeable reductions in the anthropometric and lipid levels in 30 days of follow-up, but it did not reduce the glycemic levels. Conclusions: In this study, it was shown that ginger capsules, in doses of 1.2 g a day, can help to reduce anthropometric measures and lipid levels in the population under study; however, it had no effect on the glycemic levels.

P003 INFLAMMATORY BOWEL DISEASE PATIENTS’ PERSPECTIVES OF CLINICAL TRIALS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S53-S53
Author(s):  
David Rubin ◽  
Laurent Peyrin-Biroulet ◽  
Walter Reinisch ◽  
Swati Tole ◽  
Laura Sullivan ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Health Care Providers ◽  
Online Survey ◽  
The United States ◽  
Trial Participation ◽  
Pharmaceutical Manufacturer ◽  
Care Providers ◽  
Inflammatory Bowel

Abstract Background Despite recent progress in treatment for inflammatory bowel diseases (IBD), there is a need for therapies with long-term efficacy and improved safety. Clinical trials in IBD face challenges with patient recruitment because of study designs, competitive or overlapping trials, and a limited number of eligible patients. We sought to better understand patients’ motivations, awareness of, and experience with IBD clinical trials. Methods We conducted an international survey of adult patients with IBD consisting of 2 components. The quantitative component, a 15-minute online survey, was completed by all patients. A qualitative component, a 30-minute telephone interview, was completed by a subset of patients from the United States (US). All percentages indicate results from the online survey. Results 226 patients (mean age, 41.9 y) completed the online survey. Survey respondents included patients with ulcerative colitis (52%) and Crohn’s disease (48%) from the US (n=100, 21 of whom underwent a phone interview), Brazil (n=26), Canada (n=25), France (n=25), Germany (n=25), and Spain (n=25). Ninety-six percent of respondents reported at least a basic understanding of clinical trials, and 34 (15%) were current or past clinical trial participants. Patients reported learning about trials through 1 or more sources (could select as many as applied): health care providers (42%), pharmaceutical manufacturer websites (31%), social media (30%), online support groups (28%), and foundations (18%-23%). In the survey, patients rated conversations with health care providers most helpful, but patients who were interviewed revealed that most physicians often do not initiate conversations about clinical trials, and patients typically do not ask. Primary motivators for trial participation (rated from “does not encourage me at all” to “encourages me very much”) included altruistic goals of advancing medicine (67%), potentially mitigating risks of uncontrolled IBD such as colon cancer (59%), and access to treatment options that could improve quality of life (59%) or would otherwise be unaffordable (52%). Major barriers to participation (rated from “does not discourage me at all” to “discourages me very much”) included invasive screening and monitoring (35%), concern over receiving placebo (35%), or suboptimal treatment (33%), and concerns about posttrial access to study medication (27%). The majority (68%) reported that being in a clinical trial means being a “guinea pig” for an experimental treatment. Conclusion Opportunities to improve patients’ clinical trial experience in IBD include better communication with health care providers and improved patient education about clinical trial design and ethics. Ultimately, a better understanding of the patient perspective will be important for more informed patients and potentially higher recruitment and enrollment.

scholarly journals A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Brendan P. Jacka ◽  
Jacqueline E. Goldman ◽  
Jesse L. Yedinak ◽  
Edward Bernstein ◽  
Scott E. Hadland ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Behavior Change ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Test Strip ◽  
Health Concern ◽  
Secondary Outcome ◽  
Opioid Overdose ◽  
Test Strips

Abstract Background Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Methods Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. Discussion If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial registration ClinicalTrials.gov NCT04372238. Registered on 01 May 2020

scholarly journals Evaluation of Adaptive Feedback in a Smartphone-Based Game on Health Care Providers’ Learning Gain: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Timothy Tuti ◽  
Niall Winters ◽  
Hilary Edgcombe ◽  
Naomi Muinga ◽  
Conrad Wanyama ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Low Income ◽  
Medical Emergency ◽  
Secondary Outcome ◽  
Care Providers ◽  
Learning Gains ◽  
Learning Session ◽  
Learning Gain ◽  
Adaptive Feedback ◽  
End Point

BACKGROUND Although smartphone-based emergency care training is more affordable than traditional avenues of training, it is still in its infancy, remains poorly implemented, and its current implementation modes tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with gamified approaches remains largely unexplored, despite the lack of traditional training opportunities, and high mortality rates in these settings. OBJECTIVE The primary aim of this randomized experiment is to determine the effectiveness of offering adaptive versus standard feedback, on the learning gains of clinicians, through the use of a smartphone-based game that assessed their management of a simulated medical emergency. A secondary aim is to examine the effects of learner characteristics and learning spacing with repeated use of the game on the secondary outcome of individualized normalized learning gain. METHODS The experiment is aimed at clinicians who provide bedside neonatal care in low-income settings. Data were captured through an Android app installed on the study participants’ personal phones. The intervention, which was based on successful attempts at a learning task, included adaptive feedback provided within the app to the experimental arm, whereas the control arm received standardized feedback. The primary end point was completion of the second learning session. Of the 572 participants enrolled between February 2019 and July 2019, 247 (43.2%) reached the primary end point. The primary outcome was standardized relative change in learning gains between the study arms as measured by the Morris G effect size. The secondary outcomes were the participants individualized normalized learning gains. RESULTS The effect of adaptive feedback on care providers’ learning gain was found to be g=0.09 (95% CI −0.31 to 0.46; <i>P</i>=.47). In exploratory analysis, using normalized learning gains, when subject-treatment interaction and differential time effect was controlled for, this effect increased significantly to 0.644 (95% CI 0.35 to 0.94; <i>P</i>&lt;.001) with immediate repetition, which is a moderate learning effect, but reduced significantly by 0.28 after a week. The overall learning change from the app use in both arms was large and may have obscured a direct effect of feedback. CONCLUSIONS There is a considerable learning gain between the first two rounds of learning with both forms of feedback and a small added benefit of adaptive feedback after controlling for learner differences. We suggest that linking the adaptive feedback provided to care providers to how they space their repeat learning session(s) may yield higher learning gains. Future work might explore in more depth the feedback content, in particular whether or not explanatory feedback (why answers were wrong) enhances learning more than reflective feedback (information about what the right answers are). CLINICALTRIAL Pan African Clinical Trial Registry (PACTR) 201901783811130; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5836 INTERNATIONAL REGISTERED REPORT RR2-10.2196/13034

scholarly journals The effectiveness of online metacognitive versus face-to-face counseling on anxiety and metaworry in women with a history of spontaneous miscarriage: A Randomized clinical trial

2020 ◽  
Author(s):  
Mina Ghiasi shaham Abadi ◽  
Tahmineh Farajkhoda ◽  
Hassan Zareei Mahmoodabadi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Secondary Outcome ◽  
Base Line ◽  
Satisfaction Scale ◽  
Face To Face ◽  
Group I ◽  
Significant Difference ◽  
History Of ◽  
Online Group

Abstract BackgroundOnline and face-to-face counseling interventions can be performed on women with a history of miscarriage, which causes their anxiety and metaworry.The aim of this study was to compare effectiveness of metacognitive counseling methods, online and face-to-face, on anxiety and metaworry of women with miscarriage.MethodsIn this parallel randomized clinical trial, 40 women with a history of miscarriage, anxiety and metaworry were randomly assigned to two groups (n = 20/each): group I receiving metacognitive counseling via online network and software, and group II (control) receiving face-to-face metacognitive counseling with same content and time, 90-minute sessions. Data were collected demographic form, Beck Anxiety Inventory, Wellz metaworry questionnaire and satisfaction scale. Primary outcomes included changes in the scores of anxiety, metaworry were measured in both groups in three times including at the base line, and at the end of week eight and twelve of the intervention initiation. Satisfaction with counseling method was assessed as secondary outcome at the end of week eight and twelve of the intervention beginning in both groups.ResultsIn both groups, mean score of anxiety in 12th week was significantly different from before the intervention; difference was more significant in online group (p = 0.04). In both groups, the mean score of metaworry in 12th week had a statistically significant difference compared to the beginning of the study, and the decrease was again more significant in the online group (p = 0.03). Satisfaction with the counseling method had statistically significant difference between the two groups in week eight and twelve (respectively p ≈ 0.00).ConclusionsMetacognitive counseling both online and face-to-face improves anxiety and metaworry in women with miscarriage. Online counseling was more effective, satisfying, and longer compared with face-to-face counseling method, especially in corona virus19 outbreak.Trial registration: ISRCTN, IRCT20181120041707N1, Prospectively registered, Registered 23 May 2019, https://en.irct.ir/trial/35643/ IRCT20181120041707N1

A Randomized Clinical Trial of Vision Therapy/Orthoptics versus Pencil Pushups for the Treatment of Convergence Insufficiency in Young Adults

2005 ◽  
Vol 82 (7) ◽  
pp. E583-E595 ◽  
Author(s):  
MITCHELL SCHEIMAN ◽  
G LYNN MITCHELL ◽  
SUSAN COTTER ◽  
MARJEAN TAYLOR KULP ◽  
JEFFREY COOPER ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Young Adults ◽  
Randomized Clinical Trial ◽  
Convergence Insufficiency ◽  
Vision Therapy

Effects of Conversion to a Bicarbonate/Lactate-Buffered, Neutral-PH, LOW-GDP PD Regimen in Prevalent PD: A 2-Year Randomized Clinical Trial

2017 ◽  
Vol 37 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Karima Farhat ◽  
Caroline E. Douma ◽  
E. Ferrantelli ◽  
Pieter M. ter Wee ◽  
Robert H.J. Beelen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Function ◽  
Growth Factor ◽  
Randomized Clinical Trial ◽  
Residual Renal Function ◽  
Ca 125 ◽  
Secondary Outcome ◽  
Neutral Ph ◽  
Markers Of Inflammation ◽  
Baxter Healthcare

BackgroundThe use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients.MethodsIn a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured.ResultsDuring follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI): -163.5 – 123.5 mL]; p = 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4 mL]; p < 0.0001 over 24 months), resulting in a difference of 233.7 mL [95% CI 41.0 – 425.5 mL]; p = 0.017 between the groups at 24 months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 – 0.97) p = 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local inflammation (cancer antigen [CA]125, hyaluronan [HA], vascular endothelial growth factor [VEGF], macrophage chemo-attractant protein [MCP]-1, HA and transforming growth factor [TGF]β–1).ConclusionIn prevalent PD patients, our study did not find a difference in RRF after conversion from conventional to neutral-pH, low-GDP PD fluids, although there is a possibility that the study was underpowered to detect a difference. Decline in UF during standardized PET was lower after 2 years in the Physioneal group.

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